Subperiosteal syringe device for admitting bone graft material into a subperiosteal locus

ABSTRACT

A subperiosteal syringe assembly for storing, containing and delivering bone graft material to a location within the tissue of a jaw for use in a medical procedure. The syringe assembly has a lumen body that is maneuverable within the subperiosteal tissue to deposit bone graft material at the desired surgical site. Embodiments include a lumen body that has a flat shape, such as an elliptical shape. A plunger is provided to deliver the syringe contents. The syringe may be loaded with bone graft material, and some embodiments may be supplied pre-loaded with bone graft material. An end cap seals the open end of the lumen, and may function as a septum that may be punctured with a needle to introduce a liquid substance, such as a growth factor, into the lumen where the bone material is stored. The syringe may be designed to incorporate surgical navigation and laparoscopic systems.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to devices and systems for storing anddelivering bone material and one or more growth substances, and inparticular granular bone particles or paste, and a growth factor to asubperiosteal location through a tunnel in the tissue of a patient.

2. Brief Description of the Related Art

Dental implants are widely used to replace lost or damaged teeth. Inorder for implants to be successfully installed, there must be suitablebone structure for the implant to attach to. Although technically the“implant” denotes the structure that replaces the tooth roots andprovides the foundation for synthetic teeth, it is sometimes usedinterchangeably also to refer to the teeth. Implants typically consistof a titanium screw or post that is secured within a location of the jawbone. Surgical techniques routinely involve making or refining a hole inthe jaw bone and securing the implant in the hole. Often the implant issecured with the gum tissue and bone that grow around the implant site.

Tooth damage may coincide with bone defects in the human maxilla. Forexample, there may be premature loss of teeth as a result of periodontaldisease or other disruption or trauma. In instances where there is areduction is alveolar bone volume, bone reconstruction, which mayinvolve augmentation of the existing bone, is often required.Augmentation procedures involve surgical incisions made into the tissuearound the jaw, and placement of bone material, also referred to as agraft, at a desired site that will strengthen the implant. In order tointroduce bone graft material to the location, prior methods haveinvolved making an incision to expose an area of the bone by separatingflaps of tissue, depositing the bone material in the exposed area, andclosing the incision to secure the bone graft at the location within thetissue. Bone particles are often administered together with a growthfactor to promote attachment of the bone to existing bone and thesurrounding tissue. Current methods involve utilization of a spatula ortool to position the bone graft material in the incision location.

The aging process results in changes to the skin and facial structuresthat will result in wrinkles, skins, and concavities from lack ofsupport of the facial soft tissues. The implantation of a non-resorbableor slow-resorbing bone grafting material into a subperiosteal locus mayhelp in providing support for the lips, cheeks, note, chin, and otherfacial tissues, thereby enhancing facial esthetics. A device that allowsthe delivery of the bone graft material using a subperiosteal intraoralapproach is advantageous in avoiding dermal scars.

A need exists for a device that facilitates introduction of bone graftmaterial into a reconstruction site, and in particular, a device thatmay be inserted and maneuvered within the tissue to deliver bone graftmaterial to a desired location without the need to expose the patient'sbone.

SUMMARY OF THE INVENTION

A subperiosteal syringe device is provided for facilitating the deliveryof bone to a location within the tissue of a jaw, face or elsewherewithin the body and, in particular, the delivery of particulate bonegraft material that is comprised of bone particles, and preferably agrowth factor, but may also include paste and gel like materials which,for example, may contain collagen, and binding or adhesive agents. Thedevice is constructed so that a user may position the device within thesubperiosteal tissue, and at a desired location within the subperiostealtissue to deposit the particulate bone graft material. The device isconfigured to be used inside a subperiosteal tunnel. According topreferred embodiments, the device is configured having a lumen body withan actuator, such as a plunger, that is moved within the lumen body toexpel the bone graft material from an end of the device. The deviceconfiguration preferably comprises a subperiosteal syringe designed foruse inside a subperiosteal tunnel. The device may be used as a carrierto deliver particulate bone graft material to a location inside thesubperiosteal tissue, and more particularly, to a surgical site, such asa subperiosteal pouch that is reachable through a subperiosteal tunnel.

According to some embodiments, the subperiosteal syringe device includesa lumen body portion into which bone graft material to be delivered tothe surgical site is placed. The bone graft material, for example, maycomprise granular bone particles or a bone substitute in paste form, andagents, such as growth factors, binding or adhesive substances.According to some embodiments, the syringe may be preloaded with boneparticles, and, in some embodiments, the pre-loaded bone graft materialalso may include an agent, such as a growth factor, collagen, adhesiveand binding agents.

According to some alternate embodiments, the device is constructed tocontain bone particles, within the lumen body, or a paste containingbone particles, and to also include a means for admitting a substance,such as a growth factor or a catalyst, into the lumen where the boneparticles are stored. In the device embodiments with this feature, thebone particles may be preloaded into the lumen without an agent, such asa growth factor, and, when the bone particles are ready to be used(i.e., ready for placement at the patient site), the growth factor isadmitted into the device lumen. Another preferred embodiment includesadmitting a catalyst that will cause the setting of a biphasic materialor paste into a solid or semisolid form. According to some embodiments,a means for admitting a substance to the lumen may comprise a cap fittedon the open end of the device that may be punctured, for example, with aneedle of a syringe, to introduce a liquid substance into the lumen.According to some embodiments, the syringe may be preloaded with agranular bone substitute pretreated with a biologic agent or growthfactor. According to alternate embodiments, the syringe may be loadedwith granular or paste like material, and may be combined with collagen.According to alternate embodiments, the syringe may include an automaticmixing design to be used with biphasic materials, whereby a base andcatalyst are combined to trigger a chemical or physico-chemicalreaction.

According to preferred embodiments, the device is configured as asubperiosteal syringe, and is constructed to be insertable within apassageway that has been surgically created in the jaw or facialtissues. For example, the passageway may include a path or tunnelsurrounded by tissue, and may lead to an area where the bone material isdesired to be deposited. Preferably, the device includes an end portiondesigned to guide the lumen (e.g., through a tunnel developed in thetissue) that projects forward relative to a trailing portion of thelumen. The forward projecting end portion effects a gradual raising ofthe tissue, such as the mucosa and periosteum, that forms the tunnel asthe lumen is inserted into the tunnel, and moved within the tunnel.According to some embodiments, the lumen end is beveled at the deliveryend to form a beveled opening, where a portion of the lumen wall havinga thickness of the lumen wall, forms a leading edge. The devicepreferably includes a plunger which, when actuated, is moved through thelumen body to expel the contents from the device out through the beveledopening. According to some preferred embodiments, the device lumen bodyis configured to hold a discrete amount of bone graft material, and theplunger is provided to travel a suitable length of the device to delivera suitable amount of bone graft material.

The syringes may be configured according to some embodiments, to providea beveled opening which has a curved or radial profile. For example, thecurve may be uniformly provided, or may have one or more sections ofcurvature that have a different arc profile than one or more othersections. The leading portion of the syringe also may be provided withan inwardly tapered end, which, for example, may taper toward thesyringe longitudinal axis. The taper for example, may begin at thelocation opposite the trailing edge opening, and may taper to thesyringe end. The bevel profile may be straight, or may be curved, sothat the tapered leading portion may be provided in a number ofembodiments. According to some embodiments, the leading portion of thesyringe may be configured with a wide or broader configuration tofacilitate lifting of the mucosa and the periosteum, as the syringe ispassed through a remote incision and maneuvered through a subperiostealtunnel.

The device may include markings along the lumen body to denote theamount (e.g., volume, cc's, and the like) of material dispensed from orpresent within the syringe lumen. The syringe device may includemarkings thereon that identify the depth of insertion of the device whenthe device lumen has been inserted within the patient's tissue (e.g.,such as within a subperiosteal tunnel). Markings may be used to identifypenetration depth, and, for example, according to some embodiments, maybe provided as increasing depth numbers as the distance from the beveleddelivery end increases. The sets of markings, such as the content volumemarkings, and depth markings, preferably are provided along twodifferent locations of the lumen (such as, for example on oppositelongitudinal sides).

Preferred embodiments of the device may be configured having anon-cylindrical shape lumen, which according to some embodiments maycomprise a flattened hollow structure (e.g., such as a flattened tube).Some examples of non-cylindrical shapes include oval or ellipticalshaped lumens. According to some embodiments, the subperiosteal syringedevice may have a lumen body with a flat side spanning along one side ofits length, and with a curved or arcuate shape spanning along the otherside. The device flat side provides assistance for placement of thedevice along the bone, while the curved profile on the opposite sidelength facilitates passage of the device through the tissue, andpreferably, reduces restriction during insertion as the curved surfacesengage the tissue. According to some embodiments, the subperiostealsyringe may be constructed having a curved or radial body, whichpreferably may be curved to correspond with the geometry of a jawcurvature to facilitate maneuverability within a curved tunnel path ofthe periosteum.

The subperiosteal syringe device preferably is maneuverable through theperiosteum, and in particular through a subperiosteal tunnel. Theconfiguration of the syringe is designed to minimize or eliminateimpingement on the mucosa, while allowing subperiosteal maneuverability.

The subperiosteal syringe is configured so that it is easy to load withbone particles and may accept introduction of an additional substance,subsequent to or in combination with the loading of the bone particles.According to some embodiments, the subperiosteal syringes may beprovided empty, and may be loaded with bone particles or paste materialand a growth factor by the end user. This may be done by syringing thebone graft material and growth factor into the lumen by withdrawing theplunger. Alternatively, the bone graft material and growth factor may beloaded into the open end of the subperiosteal syringe, together, orseparately.

Alternatively, the subperiosteal syringe may be pre-loaded with bonegraft material, and supplied to the end users with the bone graftmaterial in the desired particle size, paste or composition.

Subperiosteal syringes according to the invention are configured toreceive bone particles therein, and are provided with a sealingmechanism to seal the bone particles within the syringe interior. Thesubperiosteal syringes include a feature that permits a liquid substanceto be admitted to bone particles that are situated within the lumen.Subperiosteal syringes according to the invention may be providedpre-loaded with a predetermined amount of particulate, paste, or gelbone material (e.g., by weight, volume, particle size, density, and/orthe like), and may be shipped and stored with the bone particlestherein. The bone particles may be pre-treated. According to someembodiments, where it is preferable to introduce an additional treatmentagent to the bone particles at the time of their use (such as a growthfactor), the agent or growth factor may be supplied in the form of aliquid and admitted to the syringe interior (where the bone particlesare present). According to a preferred embodiment, a protective cap isprovided to cover the syringe opening. The end cap preferably isconstructed from a material that is puncturable. The bone graft materialmay be supplied preloaded within the syringe lumen body and remainssealed therein from contaminants, with the plunger head sealing one endof the lumen and the end cap sealing the other lumen end. The end cap isconstructed to permit passage of a needle therethrough, preferably by apuncture, so that a substance, such as a growth factor, may beadministered to the interior of the syringe, e.g., to the boneparticles.

Preferably, the subperiosteal syringe is constructed to minimize orprevent the separation of its component parts, fractures and/or shearingwhen the device is in use. For example, some preferred embodiments mayprovide a monolithic plunger, which includes a plunger head, shaft andactuation end. The syringe lumen body preferably is constructed from amaterial that is rigid but permits some flexibility. According to somepreferred embodiments, plastic material may be used to construct thelumen body. The plunger may be formed from a rubber, silicone, or othersuitable material that is capable of providing a seal against the lumenbody interior.

One or more of the features discussed herein, including those discussedabove, may be provided separately or together with one or more otherfeatures in subperiosteal syringes according to the invention. These andother advantages may be provided by the inventive devices shown anddescribed herein.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1A is a right side perspective view of a first embodiment of asubperiosteal syringe device according to the invention.

FIG. 1B is a perspective of the subperiosteal syringe device of FIG. 1A,as viewed looking from the right side, and showing the lumen bodyseparate from the plunger.

FIG. 1C is an enlarged perspective view of the bottom of the lumen bodyshown in FIG. 1B.

FIG. 1D is a sectional view of the plunger of the device of FIG. 1Ashown separately from the lumen, the section being taken above theplunger head and looking down the plunger shaft.

FIG. 2 is a right side view of the device of FIG. 1, shown with theplunger in a position where it is extending through the body.

FIG. 3A is a perspective of a second embodiment of a subperiostealsyringe device according to the invention, as viewed looking from theright side.

FIG. 3B is a perspective view of the bottom of the second embodiment ofthe subperiosteal syringe device shown in FIG. 3A.

FIG. 3C is a sectional view of the plunger of the device of FIG. 3Ashown separately from the lumen, the section being taken above theplunger head and looking down the plunger shaft.

FIG. 3D is a sectional view of the plunger of the device of FIG. 3Ashown separately from the lumen, the section being taken above theplunger head and looking down the plunger shaft.

FIG. 4A is a perspective of a third embodiment of a subperiostealsyringe device according to the invention, as viewed looking from theright side.

FIG. 4B is a perspective view of the bottom of the second embodiment ofthe subperiosteal syringe device shown in FIG. 4A.

FIG. 4C is a sectional view of the plunger of the device of FIG. 4Ashown separately from the lumen, the section being taken above theplunger head and looking down the plunger shaft.

FIG. 4D is a sectional view of the plunger of the device of FIG. 4Ashown separately from the lumen, the section being taken above theplunger head and looking down the plunger shaft.

FIG. 5 is a right side view of the first embodiment of the subperiostealsyringe device of FIG. 1A, shown with the end in perspective view toillustrate the opening.

FIG. 6 is a perspective view of a fourth alternate embodiment of asubperiosteal syringe according to the invention.

FIG. 7A is a perspective of a fifth embodiment of a subperiostealsyringe device according to the invention, as viewed looking from theright side.

FIG. 7B is an end view of the syringe of FIG. 7A as viewed looking fromthe end of the syringe.

FIG. 7C is a view of an exemplary depiction of an end cap for thesyringe of FIG. 7A.

FIG. 8A is a perspective of a sixth embodiment of a subperiostealsyringe device according to the invention, as viewed looking from theright side.

FIG. 8B is an end view of the syringe of FIG. 8A as viewed looking fromthe end of the syringe.

FIG. 8C is a view of an exemplary depiction of an end cap for thesyringe of FIG. 8A.

FIG. 9 is a partial view of an alternate embodiment of a syringe showingan alternate end configuration as viewed from the top, the syringe endbeing shown separate from the plunger and remainder of the lumen body.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A subperiosteal syringe device for delivering bone graft material to alocation within the tissue of a jaw, the face, or other bones, and, moreparticularly, for delivering the bone graft material via insertion ofthe device within a tunnel that has been surgically developed in thesubperiosteum of a patient. The device is useful for carrying outsubperiosteal jaw and facial augmentation or reconstruction procedures.In particular, the subperiosteal syringe is configured for carrying outprocedures where the surgical site remains hidden from view and isreachable through a tunnel within the jaw tissue that has an openingremote from the surgical site (where the bone graft is to be implanted),and where the tunnel leads to the surgical site. The subperiostealsyringe device is maneuverable within the subperiosteal tissue (e.g.,through a surgically developed tunnel) to a desired location within thetissue adjacent the bone to be augmented or reconstructed. When thedevice is positioned at a desired location (e.g., where the deviceopening is at the surgical site or pouch to receive the implant), thedevice contents, such as bone graft material that contains boneparticles, may be delivered to the site.

According to some embodiments, the syringe may be used for carrying outbone augmentation applications, with our without subsequent orconcomitant implant placement, where the graft material is placeddirectly over bone, and under the periosteum. The syringe also may beused to carry out bone graft delivery according to another embodiment,where bone graft material is added to treat implants that are lackingbone. In this latter application, the lack of bone at an implant may bea result of improper placement, or bone loss that has taken place overthe years.

Referring to FIGS. 1A-1C, there is illustrated a first exemplaryembodiment of a subperiosteal syringe device 110 for delivering bonegraft material to a subperiosteal site. According to the exemplaryembodiment, the subperiosteal syringe device 110 has a body comprising alumen 111 with a first opening 112 at one end 111 a thereof and a secondopening 113 at the opposite end 111 b thereof. The lumen 111 defines acavity 111 c therein. Preferably, the lumen 111 has a thickness 111 d,defined by the lumen wall 111 e. The lumen wall 111 e includes aninterior surface 111 f and an exterior surface 111 g.

The syringe assembly 110 is shown including a plunger 115 with a shaft116 and a head 117. The plunger head 117 is sized to fit within thelumen cavity 111 c and sealingly engages the lumen interior wall 111 f.According to preferred embodiments, as illustrated in FIG. 1A, anactuator 118 is associated with the plunger 115, and in the embodimentillustrated, the actuator 118 is provided as part of the plunger 115.The actuator 118 is designed to be manually controlled to move theplunger 115 and plunger head 117 along the lumen 111 and through thelumen passageway 111 c. The plunger head 117 preferably fits tightagainst the lumen body wall 111 e, and in particular the interior wall111 f, making an airtight seal. Preferably the seal seals air, humidityand potential contaminants from entering into the syringe body cavity111 c. Movement of the actuator 118 causes the plunger shaft 116 andhead 117 to slide through the lumen 111 and express the syringe contentsout from the second opening 113, which is the delivery opening.Preferably, the subperiosteal syringe 110 is loaded with bone graftmaterial 200 (see FIG. 2) which is contained within the lumen body 111out from which it is delivered via the syringe opening 113 to expressthe bone graft material at a surgical site. The subperiosteal syringe110 may be loaded using a suitable method, including syringing the bonegraft material into the opening 113 at the end 111 b, for example, totake up the bone graft material and any substance that is may be mixedwith it (such as a growth factor).

As depicted in FIG. 1A, the plunger 115 is configured to have a suitablelength to express a desired amount of material from the syringe 110.According to the exemplary embodiments, as depicted in FIG. 2, theplunger 115 may travel through the lumen opening 111 c a predetermineddistance so as to dispense a predetermined amount of bone graftmaterial. The bone graft material may be provided preloaded within thesyringe 110. The syringe 110 may be configured to accept and store apredetermined amount of bone graft material in its cavity 111 c until itis needed for a procedure.

The syringe 110 preferably includes a means for admitting a material tothe bone particles that are present within the syringe. Preferably, themeans for admitting material comprises a mechanism for introducing aliquid material into the lumen cavity 111 c where the bone particles arepresent.

As illustrated in the exemplary embodiment of FIG. 5, the mechanism isconfigured to comprise an end cap 400, which is made from a materialthat may be punctured with a needle. The end cap 400 is configured tosecure material (e.g., bone particles) within the lumen body 111 bymaking a tight seal against the lumen 111. The end cap is shown providedto cover the lumen opening 113, and may form a tight fit on the lumenend 111 b. The end cap 400, or at least a puncturable portion thereof,is made from a material that may be punctured with a needle. The needlemay be attached to a separate syringe (not shown), which may be loadedwith a suitable agent, such as a growth factor. The liquid, such as thegrowth factor, is delivered through the end cap 400 and into the lumencavity 111 c, and, in particular, is administered to the bone particlesresiding in the lumen 111. The end cap 400, or puncturable portionthereof, such as for example, the central area 400 a, is constructedfrom a material that is designed to receive the needle puncturetherethrough, and, upon the withdrawal of the needle from the end cap400, is designed to close the puncture opening made by the needle. Theend cap may be puncturable across its entire surface, or alternatively,may have a preferred puncture area, such as, for example, the designatedarea 400 a. Although not shown, the end cap 400 may be provided with agroove or other suitable structure, such as an indentation, a colored ordotted area, to facilitate the direction of the needle therethrough.According to some embodiments, the puncture area is configured to guidethe needle and may provide a path or guide (not shown), for facilitatinginsertion of the needle through the end cap 400.

Similarly, the end cap 400 although illustrated in connection with acylindrical lumen in FIG. 5, preferably is constructed to fit over otherlumen openings, such as where the lumen is configured with a flattened,elliptical, or has a flat side.

In the embodiment illustrated in FIG. 1A, the lumen body 111 is depictedhaving a substantially cylindrical shape. According to preferredembodiments, the plunger 115 is sized to pass entirely through the lumenbody 111. Referring to FIG. 2, the plunger 115 is illustrated in aposition within the lumen 111, where the plunger 115 has traveled alength to where it will have expressed the contents out of thesubperiosteal syringe 110. According to preferred embodiments, theplunger head 117 may have a tapering end portion 117 b which is theleading portion. The plunger end portion 117 b, for example, is shownbeing tapered, and illustrated having a conical shape. According topreferred embodiments, the plunger head is configured to comprise astructure that serves to break up agglomerations of bone particles andto prevent compaction of the particles within the syringe lumen. In theexemplary embodiment illustrated, the plunger head 117 is shown having apointed tip, which is designed to break up agglomerated bone particles.

According to preferred embodiments, the syringes 110, 210, 310, etc.,preferably have markings on the body to designate one or the other orboth of the lumen content volume and the penetration depth of thesubperiosteal syringe. The markings 190 preferably identify a measure ofthe volume of the contents, and the plunger position relative to one ofthe marking lines provides an indication of the volume of bone graftmaterial, for example, to determine an amount delivered, or an amountremaining to be delivered. The markings 190 preferably may be providedwith numerals (not shown) that increase in the direction toward theactuator end 111 a of the lumen 111 (i.e., a direction away from thedelivery end 111 b). The depth markings 196 (FIG. 1B) may denote an enddepth, which preferably may signify the distance D to the lumen body end111 b, which denotes the depth that the lumen has been inserted. Forexample, where the syringe 110 is inserted into a subperiosteal tunnel,the syringe lumen body 111 typically will be out of the sight of theuser. The markings 196 preferably may be provided with numerals (notshown) that increase in the direction toward the actuator end 111 a ofthe lumen 111 (a direction away from the delivery end 111 b). Forexample, where an indication at the marking line 197 is provided, it mayfor example, represent 7 cm insertion depth, and be marked with anumeral “7” or “7 cm” so that when the syringe 110 is positioned withina subperiosteal opening, such as a tunnel in the patient's jaw tissue,the depth of the inserted portion is identifiable by the marking 197.For example, where the syringe 110 is inserted an additional amount,such as, for example, an additional 1 cm, then, the marking line 198will represent 8 cm, and may be provided to bear a marking, e.g., “8” or“8 cm”, to identify that the insertion depth is 8 cm. Although numeralsand units have been omitted from the figures for clarity in presentingthe syringe, the syringe body 111 markings, such as those 190 and 196,may be marked with respective corresponding markings that includenumbers and units. In addition the cm lengths discussed herein are toillustrate an example of measurement, and the subperiosteal syringes ofthe invention may be made shorter or longer as desired.

The subperiosteal syringe device includes a portion designed to guidethe lumen (e.g., through a tunnel developed in the tissue) whichcomprises a leading portion of the lumen at the delivery end 111 b. Asillustrated in FIG. 1A, the leading portion 120 projects forwardrelative to a trailing portion of the lumen 121. The forward projectingportion 120 effects a gradual raising or elevation of the tissue forminga subperiosteal tunnel into which the subperiosteal syringe lumen 111 isto be inserted. The projecting portion 120 of the device 110 preferablyis used to elevate the mucosa, providing entry of the syringe lumen 111into the tunnel and facilitating movement therethrough. The projectingportion 120 preferably is configured as an extension of the lumen 120,and in the embodiment illustrated, forms a projection above a portion ofthe lumen cavity, with the underside of the projection being open. Theprojecting lumen portion 120 aids to deliver the bone graft materialfrom the syringe lumen to the desired location by directing the bonegraft material as it is being expressed toward the bone side of thesurgical site (below the projection 120), and preferably to the bonesurface.

According to some embodiments, the projection 120 may be formed byproducing a bevel in the lumen end 111 b. The lumen end 111 b is beveledat the delivery end to form a beveled opening 113, where a portion ofthe lumen wall having a thickness of the lumen wall, forms a leadingedge. As illustrated in FIG. 1A, the syringe 110 delivery end opening113 is configured to comprise a beveled opening 113 a. The beveledopening 113 a is formed by a first portion of the lumen 111 that extendsbeyond a second portion of the lumen 111. The longitudinal length of thelumen 111 is illustrated having a bevel that is depicted being disposedat about 45 degrees, although other bevel angles are possible. The bevelat the end of the syringe 110 is provided to face the bone surface (sothat the extended portion of the lumen is opposite the bone surface),for example, when the syringe 110 is used to deliver bone graft materialto a patient.

Embodiments of the syringes shown and described herein may be configuredwith configurations that facilitate insertion and maneuverability withinthe tissue of a patient, such as, for example, a subperiosteal tunnelthrough which bone graft material is to be delivered to an ultimatesurgical site accessible through the tunnel. Referring to FIGS. 3A-3C,according to an alternate embodiment, a subperiosteal syringe 210 isdepicted having a lumen 211 that is non-cylindrical. In the embodimentillustrated in FIG. 3, the syringe lumen 211 is shown having anelliptical configuration. The lumen 211 has a first opening 212 at oneend 211 a thereof, a second opening 213 at the opposite end 211 bthereof, and a cavity 211 c therein. 211 d, an interior surface 211 f,and an exterior surface 211 g. The lumen cavity 211 c is elliptical incross-section (see FIG. 3D). According to preferred embodiments, thecross-sectional shape of the cavity 211 c matches the shape of thesyringe body lumen 211, and preferably, the shape of the exteriorsurface 211 g. A projection of the lumen leading portion 220 is providedat the delivery end 211 b. According to a preferred embodiment, abeveled opening 213 a is formed by the projection 220. The projection220 is shown comprising an extended portion 211 h of the lumen 211. Theextended portion 211 h preferably is comprised of the wider arc of theellipse, so that the elliptical body 211 has a broader portion of thelumen end 211 h forming the beveled opening 213 a. The cross-sectionalview of FIG. 3D illustrates a preferred configuration with the lumenprojecting end 220 being shown.

A plunger 215 is provided to fit within the lumen cavity 211 c.Preferably, the profile of the plunger head 217 corresponds with theelliptical profile of the lumen interior wall 211 f. The plunger 215 maybe constructed with a plunger head 217, and plunger shaft 216 asdescribed and illustrated in connection with the subperiosteal syringe110, and the plunger 115. The plunger 215, shaft 216, and plunger head217 preferably are constructed from a material as described inconnection with the plunger 215. As discussed above, in accordance withpreferred embodiments, the plunger 215 may be a monolithic structurecomprising an actuator 218, shaft 216, and head 217. The plunger head217 preferably has a leading edge or tip end that may be tapered, suchas the conical end 217 a, to facilitate expulsion of the syringecontents at a desired rate. The plunger head 217 or portion of the headin sealing contact with the lumen interior wall 211 f, preferably iselliptically shaped, and may taper from an elliptical profile (where itis in contact with the lumen interior wall) to the leading end of thehead 217 which may be formed by a tapering wedge or ellipticalconverging end. The head 217, as well as the plunger head 117, may beprovided with rounded or softened edges at the trailing end, so thatwhen the plunger head 217 (and head 117) travels beyond the lumenopening 213 (and 113, as shown in FIG. 2), retracting the syringe 210from the tunnel will minimize impingement on the surrounding tissue.

According to alternate embodiments, the lumen of a syringe according tothe invention may comprise a longitudinal length with at least oneportion, such as a first portion, of the longitudinal length spanning ina longitudinal direction, and at least one other portion, such as asecond portion, of the longitudinal length spanning in a longitudinaldirection. The first portion and second portion preferably are parallelto each other. According to some embodiments, the first portion and thesecond portion may be disposed on opposite longitudinal sides of thelumen. Embodiments may be constructed so that at least one of theportions extends longitudinally beyond the other portion to form thelumen opening that will express the bone graft material, as well as toprovide a leading portion to facilitate opening of the tunnel for theportions of the lumen that trail the leading portion. The opening formedfrom the first portion and second portion may comprise a beveledopening. Referring to FIGS. 4A-4D, a third alternate embodiment of adevice 310 according to the invention is illustrated, and includes afirst portion configured to have one shape and a second portionconfigured to have a second shape. The subperiosteal syringe device 310has a body or lumen 311. The lumen 311 has a first opening 312 at oneend 311 a thereof, a second opening 313 at the opposite end 311 bthereof, and a cavity 311 c therein. The lumen wall has a wall thickness311 d which preferably represents the thickness of the lumen wall firstportion 311 e and lumen wall second portion 311 f. The lumen wallportions 311 e, 311 f preferably are constructed together to form alumen 311 comprising a first portion 311 e and second portion 311 f. Inthe embodiment depicted, the lumen 311 is constructed to have anon-uniform configuration. In the embodiment illustrated in FIGS. 4A and4B, the lumen 311 is shown having a substantially flat portion 311 fspanning its longitudinal length and forming the shorter side of thelumen at the lumen opening 313. According to preferred embodiments, thesubperiosteal syringes according to the invention may be constructedwith a flat portion, which preferably spans the length of the lumen, andon one longitudinal side thereof, as shown in the exemplary depiction ofthe syringe body or lumen 311 of FIGS. 4A and 4B. The flat portion 311 fof the syringe 310 is provided to be used against the bone surface (ofexisting bone of a patient).

In the embodiment depicted in FIGS. 4A and 4B, the lumen 311 is shownhaving a second portion 313 e that spans a longitudinal length whichforms the leading portion 320 of the lumen 311 that defines the front ofthe bevel opening 313. The second portion 313 e preferably comprises aportion that is not flat, and which preferably has a curved, radial orother type of arcuate configuration. In the embodiment illustrated inFIG. 4, the non-flat portion is shown having an elliptical configurationformed by the elliptical wall portion 311 e. Bone material is expressedfrom the syringe opening 313 and the protruding portion, which in thesyringe 310 is the leading portion 320 of the curved wall portion 311 e.

As shown in FIG. 4C, the syringe 310 preferably includes a plunger 315with a shaft 316, an actuator 318 and a plunger head 317 with a profilecorresponding to the inner wall portions of the lumen 311. The syringeplunger 315 preferably may be constructed similar to those plungers 115,215 shown and described herein, to allow introduction via a syringeneedle of a liquid (e.g., growth factor) into the cavity 311 c where thebone graft material is held. The plunger head 317 includes a firstplunger head portion that is a flat portion, and a second plunger headportion that is curved. The plunger head 317 preferably is configuredwith a profile that matches the interior wall structures of the lumen311. According to some alternate embodiments, the lumen wall thicknessmay be provided with rounded edges along the lengths where the interiorwall first portion meets with the second portion. This may be done toprovide the plunger with a curved profile at the edges. The lumenexterior may include the curved edges, or may provide more discreteedges that are different than curved edges that may be provided long theinterior of the lumen (where the interior wall first and second portionsjoin). In this latter instance, the thickness of the lumen wall may beincreased along those longitudinal edges where the first portion meetswith the second portion.

Referring to FIG. 5, the circular embodiment of the subperiostealsyringe 110 of FIG. 2 is shown loaded with bone graft material 500comprising bone particles (501, 502, 503, et seq. . . . ) disposedwithin the lumen cavity 111 c of the syringe 110. The syringe 110 isdepicted in an embodiment where it is pre-loaded with bone graftmaterial 500. The bone graft material 500 may comprise treated oruntreated material. For example, the bone graft material 500 maycomprise bone graft particles (501, 502, 503) that are treated with atreatment agent, such as, for example, a growth factor. Alternateembodiments may provide the bone graft material in the form of boneparticles which have not been treated, or, if they have been previouslytreated (at the time of or prior to loading the bone material in thesyringe), require further treatment with a substance, such as, forexample, a growth factor, or a biologic adhesive or binding agent.Additional alternative embodiments may provide a graft material in theform of a paste, or in combination with collagen, both of which may betreated or untreated with a biologic agent such as a growth factor,biologic adhesive or binding substance; or to which a biologic agentsuch as a growth factor, biologic adhesive or binding substance may beadded. The bone graft material 500 is contained within the syringe 110between the plunger head 115 and the end cap 400. The bone graftmaterial 500 is bounded by the plunger head 117 shown positioned nearthe lumen second end 111 b. The plunger head 117 has a periphery whichseals against the interior wall 111 f of the lumen body 111. The end cap400 is provided to cover the opening 113 at the first end or deliveryend 111 a, and is removable prior to use of the loaded syringe 110. Theend cap 400 preferably is constructed from a silicone or rubber materialthat is inert or does not react with the bone graft material 500 or anyof the treatment agents (e.g., growth factor) that are added to orrequired to be added to the bone graft material 500. The cap 400 may besecured to the lumen end 111 a using any suitable means, such as forexample, tension, pressure or friction, adhesive, heat, a band, retaineror the like, or combinations of these. The bone graft material 500 maybe stored in the syringe 111, and the syringe 110 may be shipped anddelivered to end users, preloaded with bone graft material 500, and withthe plunger 115 installed in the syringe lumen cavity 111 c and the endcap 400 secured to the open end 111 a. The cap 400 may be configured tohave a profile that matches the opening 113, such as, for example, wherethe opening is cylindrical, elliptical, flat, or combinations of theseshapes, and the cap 400 also is secured over the opening 113, and fitsthe leading edge or projection, such as a bevel at the end of the lumen111. The end cap may be configured to match the profile of the lumenprojection, and fit over the projection and seal the lumen opening.Growth factor solutions, for example, may be injected through the endcap 400. According to some embodiments, the end cap 400 is provided witha preferred area that comprises a puncturable area, see e.g., the area400 a in FIG. 5). The cap 400 may therefore contain the bone graftmaterial 500, as well as any liquid injected into the cavity 111 c, suchas the growth factor, within the lumen 111. The contents of the syringe110 are sealed, and provide for the bone graft material to be depositedin the lumen 111 and stored and shipped for distribution to end users.

The syringes according to the invention, such as those syringes 110,210, 310, 410, 510 and 610 shown in the exemplary embodiments, also maybe packaged is a sealed packaging or container, or otherwise encased,such as, in airtight or vacuum type packaging, to further protect thesyringe and its contents. The sealed syringe (sealed by the plungerhead, and with an end cap) may be packaged in packaging that may beremovable from the syringe, or from which the syringe may be removedwhen it is needed for use.

As shown in FIG. 6, a fourth alternate embodiment of a subperiostealsyringe 410 according to the invention is shown. The syringe 410 issimilar to the other embodiments, and may have one or more of theshapes, including elliptical, round, flat-sided, or combinationsthereof, where the lumen is curved to arc over its length. The curvatureor arc may be uniform, such as radially configured, or may benon-uniform, with multi radial curvatures. The plunger 415 preferably isconfigured to correspond to the lumen inner profile, and make a sealagainst the lumen interior wall. The plunger 415 preferably isconstructed so that the plunger shaft 416 fits within the curved lumen411, and may move the plunger head 417 through the curved lumen cavity411 c. The plunger shaft may comprise a coil, curved element, orflexible element that is capable of movement within the confines of thecurved lumen cavity 411 c, and to provide a force, when depressed, tomove the plunger head 417 forward in the lumen 411. Preferably, theplunger head 417 may move beyond the opening 413. The actuator 418 isshown provided at the end of the plunger 415, opposite the end of theplunger head 417. The lumen opening 413 may be provided with a leadingportion 420. The curved embodiment may be constructed with any of thepreferred shapes, such as those shown and described herein in connectionwith the embodiments of the subperiosteal syringes 110, 210, 310 shownand described herein. For example, according to one embodiment, thecurved syringe 410 may include a syringe lumen 411 with a flat side,such as, for example, the side 411 f shown in FIG. 6, which may beinserted and guided along the bone side of a subperiosteal tunnel withinwhich the subperiosteal syringe is guided. Alternatively, the lumen maybe elliptically configured, or have a circular lumen body. The plungermay be radial, and, where a curved syringe embodiment is constructedwith a lumen is not consistently radial along its length, the plungermay be provided to be moved along the lumen cavity (such as the cavity411 c shown in FIG. 6), by providing the plunger shaft as a coil, orcomprised of compressible portions or members that provide suitablerigidity for moving the plunger head forward in the lumen and expressingthe syringe contents, while being able to move through the lumen cavity411 c. According to embodiments, the lumen 411 may be provided to havean extended portion, such as the extended portion 420 shown in FIG. 6,which is provided on the opposite longitudinal side of the lumen 411that is designed to be closest to the bone side of a tunnel within whichthe subperiosteal syringe, such as the syringe 410, is inserted.Although the subperiosteal syringe 410 is shown in FIG. 6 having acurvature, the curvature may be less pronounced than what is illustratedin the exemplary embodiment. In addition, the curvature may be providedto curve in another direction, such as an opposite direction. The curvedsubperiosteal syringe also may be constructed with the lumen protrudingportion (at the lumen opening) provided as a radially inner portion,versus a radial outward portion (e.g., FIG. 6), where the radially outerportion ends before the radially inner portion to form a beveled openingwith a different orientation.

According to embodiments, the syringe bevel may be curved between theleading end of the lumen body and the trailing end where the openingbegins. Turning to FIG. 7A, an alternate embodiment of a syringe 510 isshown. The syringe 510 is illustrated with the leading portion 520having a leading edge 520 a, and a trailing edge 521 where the frontopening 513 begins. The leading edge 520 a, is arcuate, as shown in thefront end view of FIG. 7B. The lateral portion of the lumen thatconnects the leading edge 520 a with the trailing edge 521 is shownhaving a curved configuration, which, in the example illustrated, has aprofiled edge 520 b at the opening 513 that curves inwardly or concavewith respect to the lumen body 520. The syringe is illustrated in a sideelevation view, and may be symmetrical having a respectively similarcurved portion on the other side. According to preferred embodiments,the syringe bevel may be angled equal to or greater than about 60degrees.

According to some alternate embodiments, the syringe may have a firstcurved portion, such as the curved profiled edge 520 b on one side andhave a non symmetrical profiled edge on the other side. This embodimentis designed to guide the expression of the syringe contents in adirection away from the leading portion and any extended side portion orprofile. For example, a profiled edge on one side may be recessed orcurved into the body 520 more than the profiled edge on the other side.

The embodiments of the syringes may include a mechanism, such as, forexample, a stop, to prevent the plunger movement from moving beyond apredetermined position or distance. In the embodiment illustrated inFIGS. 7A and 7B, the plunger is shown with the plunger seal or headportion 517 extending to the trailing edge 521 of the syringe 510. Inthe embodiment illustrated, the plunger head 517 has a tapered portion517 a with a pointed end 517 b to break up particles engaged by theplunger head 517. The profile of the plunger head, preferably is conicalor has a sloped surface configuration. According to some embodiments,the plunger head profile at the leading end aligns with the bevelprofile angle of the lumen 520.

The end cap 600 (FIG. 7C) preferably may be configured having a shapethat matches the bevel profile to provide a seal over the lumen endopening 513.

According to another alternate embodiment, a syringe 610 is provides.The syringe 610 includes a leading portion 620 having a bevel at the endof the syringe which forms the opening 613. In the embodimentillustrated, the bevel is shown having a curved profile, with theopening 613 spanning from the end of the leading edge 620 to thetrailing edge 621. The upper leading portion 620 a is shown beingtapered inwardly toward the central axis A of the syringe 610. Theinward taper directs the bone material expressed from the syringe 610 ina directional manner, which preferably is toward the bone surface.According to preferred embodiments, the plunger head 617 has a taperedportion 617 a and a pointed leading end 617 b, and preferably extends tothe end of the lumen opening 613. According to some preferredembodiments, the plunger head 617 preferably may be configured to alignwith the taper of the bevel and particularly with the upper leadingportion 620 a. For example, according to some embodiments, the plungertaper 617 a may engage the interior 620 b of the leading portion 620 a.According to some embodiments, the plunger head configuration may beprofiled to correspond with the taper or profile of the upper leadingportion 620 a so that the plunger head 617 a, or portion therefor, maysealingly engage the interior surface 620 b of the lumen of the leadingportion 620 a. Similarly, an end cap 700 (FIG. 8C) may be configured tofit onto the leading end 620 of the syringe 610.

Syringes preferably may include a stop mechanism to limit the movementof the plunger. For example, in FIG. 7A a stop mechanism is showncomprising a stop element 540 disposed on the plunger shaft 516, whichis situated a distance from the plunger end so as to limit the travel ofthe plunger head, and provide the limit position of the plunger. Forexample, according to some preferred embodiments, the syringes disclosedherein may be provided with a stop mechanism, and the plunger head maybe limited and controlled by the stop mechanism to prevent its travelbeyond the lumen opening 513. Similarly, the other syringes shown anddescribed herein also may be provided with a stop mechanism to limit theplunger travel. For example, the stop mechanism may limit the plungerhead travel to a location at or before the beginning of the lumenopening. In the embodiment of the syringe 610 shown in FIGS. 8A, 8B and8C, the plunger travel may be limited by the bevel leading portion 620.The plunger head 617 may engage with the inwardly tapered wall of theleading portion 620 to stop further travel of the plunger 615.Alternatively or in addition, the syringe plunger 615 may be providedwith a stop mechanism, such as, for example, the stop 640.

The syringes shown and described herein, although depicted with astraight profile at the opening, may be configured with a curved profileopening, including, for example, the curved profile shown and describedin the syringe embodiments 510 and 610 of FIGS. 7A-7C and 8A-8C,respectively. In addition, syringes shown and described herein, althoughdepicted with a parallel leading edge profile at the opening, may beconfigured with an inwardly tapered or angled leading portion,including, for example, the inwardly tapered angled profile shown anddescribed in the syringe embodiment 610 of FIGS. 8A-8C.

Embodiments of the syringes may provide variations of the bevel, withsome bevels having a bevel profile, when viewed from the side, that isstraight, while other embodiments provide a bevel profile that iscurved. Alternate embodiments may be configured the leading edge of thebevel to have more area so that bone material expressed from the syringelumen opening 613 may be directed by the leading portion. For example,the leading edge may include a leading portion that is partiallycylindrical, or radial in cross section (taken perpendicular to thesyringe central axis A). FIG. 9 illustrates an alternate configurationfor the leading portion which may be tapered or angled, or straight,which has a widened leading portion 820 as shown by the double arrow W.

The syringes may be constructed with one or more combinations of thefeatures disclosed herein. For example, some embodiments may provide asyringe having a straight leading edge with straight bevel. For example,the bevel may have a profile that provides a linear dimension whenviewing the syringe from the side from the leading edge to a trailingedge at the syringe opening. Alternatively, the syringe may beconstructed having a straight leading edge with a concave bevel, so thatthe side profile of the syringe exhibits a concavity from the leadingedge to the trailing edge at the syringe opening. According to otherembodiments, the syringe may be constructed with an angled leading edge,which preferably is angled toward the central axis of the syringe lumen.The angled leading edge may be provided with a bevel profile, as viewedfrom a side view that is straight from the angled leading edge to thetrailing edge, or according to an alternate configuration where thebevel profile is concave from the leading edge to the trailing edge. Thedegree of concavity may be provided and may be a uniform arc or radius,or, according to some embodiments may have multiple radial portions overits dimension. For example, the profile may provide a larger radialdegree at a portion closer to the leading edge of the bevel, and mayprovide a smaller radial dimension at the portion closer to the trailingedge. Other embodiments may be skewed inwardly, so the radial bevelprofile is pulled inwardly of the opening, relative to a straight lineprofile from the leading edge to the trailing edge. In the syringesshown and described herein, the leading edge is designed to provide asmaller profile for the leading portion of the syringe to enter thetunnel via the remote incision while also providing the ability toelevate the mucosa and the periosteum when the syringe is inserted intoa remote incision and maneuvered through the subperiosteal tunnel.According to some embodiments, the inward taper of an angularly providedbeveled leading edge may further direct the expressed bone material,such as bone particles, to the bone surface.

As with the syringes disclosed herein, the bevel configurationfacilitates insertion into the laparoscopic tunnel, and providing theleading portion serves to elevate the mucosa. The leading edge isconfigured to direct the bone particles to the bone surface.

Alternative embodiments include the use of surgical navigation orlaparoscopic camera systems to assist in maneuvering the syringe withinthe subperiosteal tunnel, and delivering the bone graft particles withinthe subperiosteal pouch. The surgical navigation and laparoscopicequipment may be attached to the subperiosteal syringe, or incorporatedinto the design of the subperiosteal syringe. For example, a portion ofthe syringe body that remains external to the subperiosteal tunnel maybe modified to accept the attachment of positioning devices as part of asurgical navigation system. An alternative embodiment may include anendoscopic or laparoscopic camera assembly that is attached orincorporated into the body of the subperiosteal syringe.

According to some preferred embodiments, as shown in the exemplaryembodiments illustrated, the subperiosteal syringes 110, 210, 310, 410,510 may be constructed having a cross-sectional profile that has auniform width along the length of the lumen 111, 211, 311, 411, 511.According to preferred embodiments, the lumen cross-sectional profilepreferably is maintained along the length of the lumen body through thedelivery end of the lumen, and at the delivery end opening. A leadingportion of the lumen that forms the projection, according to preferredembodiments, may be dimensioned within the lumen cross-sectionalprofile, to represent the cross-sectional profile over its extendedlength. According to alternate embodiments, such as the syringe 610(FIGS. 8A-8C), the cross-sectional profile may be uniform with theleading portion having a different cross-sectional profile.

According to some embodiments, a syringe, such as, for example, any ofthose syringes 110, 210, 310, 410, 510, 610 is provided with a lumen(111, 211, 311, 411, 511, 611) having bone graft material 500 therein.The bone graft material may comprise particulate bone matter, or,according to some alternate embodiments, may comprise a bone substitutein paste form. The bone graft material may include bone particles thatare provided in a size range between about 0.25 and 1.0 mm in diameter,and preferably may be provided within a range of about 0.50 to 1.0 mm indiameter (the diameter being a rough diameter for bone particlemeasurement as the particles are not typically uniform). An amount ofabout 0.25 grams to about 0.5 grams of the bone particles are pre-loadedinto the subperiosteal syringe (such as those 110, 210, 310, 410, 510,610), although alternative embodiments may include larger amounts ofbone particles. The bone particle granules (particulate bone material)remain loosely packed in the syringe. An end cap, such as the cap 400,is provided to seal the subperiosteal syringe opening against intrusivematerials (e.g., air and moisture) as well as to prevent leakage of thebone graft material out from the syringe. According to some embodiments,the bone material may be supplied in the syringe along with anothersubstance, such as, for example, a growth factor, collagen, a biologicadhesive or binding agent. The pre-loaded syringe may be provided withdesired bone material, such as, for example, bone particle graftmaterial (e.g., based on size or amount) or bone paste, and may bedelivered to the medical personnel user or facility and stored untilneeded. A liquid substance may be administered to the bone graftmaterial in the syringe by admitting it through the plunger head, andmore preferably, by injecting it using a needle that is inserted throughthe plunger head. In addition, the end cap 400 may be removed to permita suitable instrument to be inserted (if needed or desired), to mix orbreak up any agglomerations of particles that may have formed duringstorage or shipping. The syringe embodiments shown and described hereinmay be used to conduct jaw, face, or bone reconstruction procedures,where augmentation of the bone is accomplished by introducing bone graftmaterial to the surgical site. According to some preferredimplementations, the syringes are useful for maneuvering the lumencontaining bone graft material through a tunnel developed at thesurgical site that leads to a pocket or pouch where the bone material isdesired to be deposited in order to develop the bone at that location(which may augment the existing bone of the patient). This procedure maybe carried out to install implants, and synthetic teeth in the mouth ofa patient, to augment facial bones to support facial tissues and enhancefacial esthetics, or to augment bone in any location within the bodywhere a subperiosteal approach is advantageous. The bone graft material,according to some embodiments, may comprise a paste which may comprise abinding or adhesive agent mixed with bone particles, and which,according to some embodiments, may further include one or more ofcollagen and/or growth factors. The syringe may be provided with thebone paste, and/or one or more of the optional materials. Alternatively,bone paste material may be activated with a catalyst so that the bonepaste will set in a solid or semi-solid form following its applicationto the surgical site. The catalyst, for example, according to someembodiments, may be provided to trigger a biologically beneficialchemical reaction, such as, for example, the release of a substance,such as growth factors. According to some embodiments, the catalyst maybe injected into the syringe lumen (where the bone material iscontained) through the sealing cap (such as, for example, the cap 400)at the end of the syringe.

According to some alternative embodiments, the syringe may beconstructed with a mixing mechanism incorporated into the syringe, sothat both bone material and a catalyst or other substance desired to bekept separate from each other until use, may be separately stored inseparate compartments within the syringe, and may be brought together inthe syringe when desired (when ready to be used). For example, accordingto an alternate embodiment, the mixing mechanism may comprise anautomatic mixing mechanism that is incorporated into the syringe,whereby pressure from the plunger causes a base (of bone material orpaste) and catalyst to flow from separate chambers into an automixingspiral mechanism. Preferably the separating and mixing mechanisms,including the automixing mechanism, are contained within the syringe.According to this alternate embodiment, the syringes may be configuredto contain separate component chambers loaded with separate components(bone material/paste in one chamber, and growth factor and/or catalystin another).

According to preferred embodiments, the subperiosteal syringe isconfigured to promote a uniform expression of the bone graft materialfrom the lumen body to the surgical site. As depicted in thesubperiosteal syringe exemplary embodiments 110, 210, 310, and 410 shownand described herein, the lumen body preferably provides an unobstructedpathway for the bone material to move through. The subperiostealsyringes are configured to express the bone material from the syringeinto the surgical site by controlling the depression of the plunger. Theprotruding end portion and lumen passageway control the expression ofthe bone material from the lumen by directing the material toward thebone. Referring to FIG. 5, bone material, such as bone particulatematerial, preferably is loaded into the syringe lumen body. According tosome preferred embodiments, the lumen body is dimensioned to accommodatebone particles ranging between about 0.25 and 1.0 mm in diameter. Somepreferred dimensions for the subperiosteal syringes include lumenshaving diameters from between about 2 to 7 mm, and preferably from about3 to 6 mm, and more preferably from about 3.5 to 5.5 mm. According tosome embodiments, the syringe diameter may be between about 3 to 4 mm.According to some embodiments, where the lumen is provided having anelliptical configuration, the width of the elliptical lumen bodypreferably is greater than the height. The width preferably spans thelongitudinal direction and includes the protruding portion (see e.g.,the leading portion 220 in FIGS. 3A, 3B and 3C). The width isrepresented by a double arrow 251 (FIG. 3C) and the height isrepresented by the double arrow 250 (FIG. 3B). According to a preferredembodiment, the width to height ratio is from about 2:1 to about 4:1,with a preferred range being about 3:2. According to a preferredembodiment, a subperiosteal syringe is configured having a height ofabout 3.5 mm and a width of about 5.5 mm. Preferably the height andwidth dimensions may be internal dimensions. For example, theelliptically configured subperiosteal syringe 210 shown in FIGS. 3A-3D,may be constructed with a height 250 (FIG. 3B) of about 3.5 mm and awidth 251 (FIG. 3C) of about 5.5 mm. For example, according to oneproposed example, bone graft material in the form of particulate bone inan amount of from between about 0.25 grams to about 0.5 grams, andhaving diameter ranges from between about 0.25 to 1.0 mm, is loaded intothe lumen of a subperiosteal syringe having an elliptical configuration,such as the subperiosteal syringe 210 shown and described herein, with aheight of about 3.5 mm and a width of about 5.5 mm, and an overalllength of about 15 cm, with the plunger positioned 3 cm of the 15 cmlength, providing 12 cm of lumen length in which the bone material isloaded. The volume occupied by the bone material, in this proposedexample, is V, which may be determined by expression (1):V=πWHL/4  (1),where V is the volume, W is the width of the elliptical lumen, H is theheight of the elliptical lumen, and L is the length of the lumen (thatthe bone material will occupy). Applying the formula to the proposedsubperiosteal syringe,V=π*5.5*3.5*12/4V=181.5 cubic mm (or mm{circumflex over ( )}3).

It is noted that the lumen end portion that is beveled may be subtractedfrom the final value V to make an adjustment due to the sloped end.Alternatively, the lumen length is taken at a point midway of theprotrusion of the leading projection.

Taking the volume of 181.5 mm{circumflex over ( )}3, and the bone graftmaterial being between about 0.25 g to 0.5 g, the bone material densitywithin the lumen may be determined. Taking 0.25 g/181.5 mm{circumflexover ( )}3 results in 0.00138 g/mm{circumflex over ( )}3, and taking 0.5g/181.5 mm{circumflex over ( )}3, results in twice the value or 0.00275g/mm{circumflex over ( )}3. According to the proposed example, boneparticle material is loaded in the syringe at a density of from about0.00138 g/mm{circumflex over ( )}3 to about 0.00275 g/mm{circumflex over( )}3.

Alternatively, the bone graft material may be provided in the form ofparticulate bone material, in a density of from about 0.001 to about0.005 g/mm{circumflex over ( )}3.

According to preferred embodiments, the subperiosteal syringes, such asthose 110, 210, 310, 410, 510 and 610, shown and described herein, maybe constructed with lengths suitable to reach the surgical site wherethe syringe contents, namely, the bone material, will be deposited. Thesubperiosteal syringes 110, 210, 310, 410, 510, 610 are configured to bemaneuvered through a subperiosteal tunnel. According to some preferredembodiments, syringes may be constructed with lumen lengths of fromabout 5 to 20 cm, and preferably from about 5 to 15 cm, with the lengthsbeing measured from the tip of the end of the lumen barrel to the tip ofthe syringe. The subperiosteal syringe diameters, which preferably maybe internal diameters, preferably range from about 3 to 8 mm, and morepreferably from about 3 to 6 mm. The syringe diameters according topreferred embodiments are provided along the length of the lumen.

The syringes shown and described herein preferably are constructed froma material that allows visibility into the lumen cavity. The materialfrom which the subperiosteal syringe lumen is constructed minimizes oreliminates fractures and/or shearing when the syringe is in use, andprevents or minimizes separation of the assembly parts. The syringelumen (such as, the lumen 111, 211, 311, 411, 511, 611) preferably isconstructed from a suitable material that provides maneuverability ofthe syringe through the subperiosteal tunnel. According to preferredembodiments, the plunger may be provided as a monolithic plunger, whichincludes a plunger head, shaft and actuation end that preferably areprovided a single component. Alternatively, some embodiments of theplunger may be comprises as a single component, where the moldingmaterial may be different for parts of the plunger (e.g., actuator,shaft, and/or head). For example, the syringe lumen body preferably maybe constructed from any suitable material that is sufficiently rigid tobe maneuvered through a subperiosteal tunnel, while at the same timepermitting some flexibility. The plunger is provided to glide smoothlywithin the lumen, with light to moderate pressure, allowing for thecontrolled expression of the graft material into the subperiosteal pouchor tunnel. According to preferred embodiments, the plunger shaft issufficiently flexible to allow bending under a certain degree ofpressure that may be encountered when the graft material has been packedwith excessive density, therefore preventing a burst of the graftmaterial from being suddenly expressed into the subperiosteal pouch ortunnel. Some examples of suitable materials are plastic materials, whichmay be used to construct the lumen body. The plunger may be formed froma rubber, silicone, or other suitable material that is capable ofproviding a seal against the lumen body interior. The materials used forthe plunger and lumen are selected to be inert or non-reactive to thebone graft material and any agent added thereto, as well as tosterilization substances or procedures used to prepare and/or load thesyringe. The subperiosteal syringe lumen may be produced by extrusion,injection molding, or other suitable process. The plungers shown anddescribed herein may be produced using similar methods, any, optionally,may be produced using overmolding to provide more rigidity to one ormore portions of the plunger, such as, the actuator, shaft, head, orportions and/or combinations thereof. The subperiosteal syringespreferably are provided for a single use, and are discarded after use.

The subperiosteal syringe device contents, such as particulate bonematerial, are expressed from the opening in the lumen through theactuation of a plunger. The plunger is depressed to deliver bone graftmaterial from the syringe to the location where the syringe lumenopening is positioned (e.g., within the patient). The plunger head maybe configured to control the rate or dispersion of the material from thesyringe. Examples of plunger heads are depicted according to preferredembodiments as being tapered, with a tapered end centrally positioned,relative to the lumen opening. The markings on the syringe lumen bodymay be used to provide a measurement of the penetration depth of thesyringe into a tunnel, or a volume of material loaded into or dispersedfrom the syringe. The syringe may be withdrawn a known distance, forexample 1.0 cm, based on the markings provided on the lumen body, sothat during the withdrawal of the syringe, the contents may be expressedto deliver content along the 1.0 cm withdrawal path. The syringevolumetric markings may provide an indication of the amount of materialexpressed from the syringe, e.g., into the surgical site.

Features discussed and shown herein in conjunction with one or moreembodiments of the syringe devices may be combined with one or morefeatures and implemented together. In addition, although not shown,accessories, including mechanisms may be configured to provide actuationof the plunger to express material from the syringe. This may beaccomplished through the coupling of an electronic control to drive themovement of the plunger. The control may be provided as a button orswitch that the user may affix to an instrument, or comprise a footswitch or other means of actuations. The lumens are shown having aprotruding portion, and although shown and described in an exemplaryembodiment having an angle at about 45 degrees, however, other bevelangles are possible. For example, the lumen may be provided having asmaller angle (relative to the protruding lumen profile) so that theprotruding portion of the lumen extends further from the trailingportion, to increase the bevel, thereby reducing the angle that the tipmakes with the trailing lumen. For example, according to some alternateembodiments the bevel angle may be between about 30 to 35 degrees.According to preferred embodiments disclosed, the amount of bonematerial provided in the subperiosteal syringe, preferably is betweenabout 0.25 and 0.5 g of bone material (such as bone particles), however,according to some alternative embodiments, bone material (such as boneparticles) may be provided in the syringe lumen at amounts of up to 1.0g. In addition, although described in connection with delivering bonematerial to augment the existing bone by developing a tunnel and pouchat a location to deliver bone graft material between the bone and theperiosteum, alternatively, the syringes may be used to deliver bonematerial to an already existing implant that is lacking in bone e.g., asa result of improper placement, or bone loss that has taken place overthe years. While the devices of the invention have been disclosed indetail, and the preferred embodiments and best mode for practice of theinvention have been similarly disclosed, the scope of exclusive rightsto which the invention is entitled is defined by the claims appendedhereto and by equivalents that perform substantially the same functionin substantially the same way to achieve the same result.

What is claimed is:
 1. A subperiosteal syringe-elevator assembly forseparating the periosteum and admitting particulate bone graft materialwithin a subperiosteal tunnel, comprising: a) a lumen body having aninsertable portion; b) the lumen body having a first opening that isconfigured for insertion into the subperiosteal tunnel and forexpressing particulate bone graft material to exit the syringe-elevatorthrough said first opening, and a second opening configured to remainoutside the subperiosteal tunnel during use; c) the lumen body having acavity therein with an uninterrupted surface and a continuous diameter;d) a plunger sealingly engaging the lumen cavity and being sized to fitwithin the lumen cavity, and that is introduced through the secondopening; e) the lumen terminating at the first opening and having aleading elevator portion that at the first opening extendslongitudinally beyond another lumen portion and is used to gain accessto the subperiosteal tunnel; f) wherein the lumen body is a sufficientlyrigid monolithic structure having a continuous lumen wall without astepped portion, said wall forming said leading portion, and whereinsaid leading portion comprises a leading edge; g) wherein said lumenwall has a cross-sectional profile having a uniform width along theinsertable portion of the lumen body; and h) wherein said lumen firstopening is beveled at the point of exit.
 2. The subperiostealsyringe-elevator assembly of claim 1, wherein said plunger has anactuator.
 3. The subperiosteal syringe-elevator assembly of claim 2,wherein the plunger is movable within the lumen cavity to slide apredetermined distance through the lumen cavity.
 4. The subperiostealsyringe-elevator assembly of claim 3, wherein said first opening isconfigured for delivery of material from said lumen cavity, wherein saidfirst opening is defined by said lumen wall, wherein said plunger has aplunger head, and wherein said plunger is movable to extend the plungerhead to a position that is at least partially beyond the lumen wallforming the first opening.
 5. The subperiosteal syringe-elevatorassembly of claim 1, wherein said lumen includes a first portion and asecond portion, wherein at the first opening said lumen first portionincludes a projecting portion that projects beyond the lumen secondportion.
 6. The subperiosteal syringe-elevator assembly of claim 5,wherein said lumen wall has a longitudinal length, and wherein saidplunger path of travel is coextensive with said lumen wall longitudinallength.
 7. The subperiosteal syringe-elevator assembly of claim 1,wherein said lumen has a non-cylindrical cross-sectional profile.
 8. Thesubperiosteal syringe-elevator assembly of claim 7, wherein said lumenhas an elliptical profile.
 9. The subperiosteal syringe-elevatorassembly of claim 1, wherein the first opening comprises an opening forexpressing the subperiosteal syringe-elevator contents therethrough, thesubperiosteal syringe-elevator including plurality of markings thatindicate a distance from a respective one of the markings to thesubperiosteal syringe-elevator end having the first opening, whereinsaid markings provide an indication of the subperiostealsyringe-elevator insertion depth.
 10. The subperiosteal syringe-elevatorassembly of claim 1, including an end cap, and bone graft materialdisposed within the lumen and bounded between the plunger at one end ofthe lumen and the end cap at the other end of the lumen.
 11. Thesubperiosteal syringe-elevator assembly of claim 10, wherein the bonegraft material comprises particulate bone particles.
 12. Thesubperiosteal syringe-elevator assembly of claim 10, wherein the bonegraft material comprises a bone substitute or synthetic bone paste. 13.The subperiosteal syringe-elevator assembly of claim 10, including oneor more substances selected from the group consisting of growth factorsand collagens.
 14. The subperiosteal syringe-elevator assembly of claim10, wherein the bone graft material disposed within the lumen andbounded between the plunger at one end of the lumen and the end cap atthe other end of the lumen is provided in an amount of 0.25 g to 1.0 g,and wherein the bone graft material comprises one or more of particulatebone particles, a bone substitute, or a synthetic bone paste.
 15. Thesubperiosteal syringe-elevator assembly of claim 14, wherein the bonegraft material is bone particles having an average particle sizediameter range from between about 0.25 and 1.0 mm.
 16. The subperiostealsyringe-elevator assembly of claim 1, wherein said lumen has a width anda height, and wherein said leading portion is provided between the widthand defines a top of the height.
 17. The subperiosteal syringe-elevatorassembly of claim 16, wherein said ratio of the width to the height isfrom about 2:1 to about 4:1.
 18. The subperiosteal syringe-elevatorassembly of claim 16, wherein said width is about 5.5 mm and whereinsaid height is about 3.5 mm.
 19. The subperiosteal syringe-elevatorassembly of claim 16, wherein said lumen cavity has an interior surface,wherein said lumen wall has a longitudinal length, wherein the lumenheight is coextensive along the lumen longitudinal length, wherein thelumen width is coextensive along the lumen longitudinal length, andwherein said plunger path of travel is coextensive with said lumen walllongitudinal length, wherein the plunger path of travel is defined bythe lumen height and lumen width, wherein the plunger has a head makinga seal against said lumen cavity interior surface, and wherein saidplunger head has a width and height ratio that is coextensive with thecross-sectional ratio of the lumen width and height.
 20. Thesubperiosteal syringe-elevator assembly of claim 16, wherein saiddensity of bone particle material in said syringe-elevator lumen is fromabout 0.001 to about 0.005 g/m{circumflex over (m)}3.
 21. Thesubperiosteal syringe-elevator assembly of claim 1, wherein the lumenhas a longitudinal length and is curved to arc along its longitudinallength, and wherein the plunger is configured to move through the curvedlumen.
 22. The subperiosteal syringe-elevator assembly of claim 1,wherein said first opening has a curved profile.
 23. The subperiostealsyringe-elevator assembly of claim 1, wherein said lumen body comprisesa longitudinal length with at least one first portion of saidlongitudinal length spanning in a longitudinal direction, and at leastone second portion of said longitudinal length spanning in alongitudinal direction parallel to the first portion; wherein saidsecond portion of said longitudinal length extends longitudinally beyondsaid first portion of said longitudinal length to form the firstopening, wherein said second portion of said longitudinal length formsthe leading portion and extends longitudinally beyond said first portionof said longitudinal length.
 24. The subperiosteal syringe-elevatorassembly of claim 23, wherein said second portion of said longitudinallength that extends longitudinally beyond said first portion of saidlongitudinal length to form the first opening is inwardly tapered. 25.The subperiosteal syringe-elevator assembly of claim 23, wherein saidlumen has an elliptical profile.
 26. The subperiosteal syringe-elevatorassembly of claim 25, wherein said second portion of said longitudinallength that extends longitudinally beyond said first portion of saidlongitudinal length to form the first opening is inwardly tapered. 27.The subperiosteal syringe-elevator assembly of claim 1, wherein saidlumen opening opens in the direction of said longitudinal length. 28.The subperiosteal syringe-elevator assembly of claim 1, wherein theplunger travel includes travel within the insertable portion of thelumen body.
 29. The subperiosteal syringe-elevator assembly of claim 1,wherein the second opening, and wherein the syringe-elevator is sealedwith the plunger head and an end cap.
 30. The subperiostealsyringe-elevator assembly of claim 1, wherein the lumen body continuouswall has a continuous diameter.
 31. A subperiosteal syringe-elevatorassembly for separating the periosteum and admitting particulate bonegraft material within a subperiosteal tunnel, comprising: a) a lumenbody having an insertable portion; b) the lumen body having a firstopening that is configured for insertion into the subperiosteal tunneland a second opening configured to remain outside the subperiostealtunnel during use; c) the lumen body having a cavity therein with anuninterrupted surface and a continuous diameter; d) a plunger sealinglyengaging the lumen cavity and being sized to fit within the lumencavity, and that is introduced through the second opening; e) the lumenterminating at the first opening and having a leading elevator portionthat at the first opening extends longitudinally beyond another lumenportion and is used to gain access to the subperiosteal tunnel; f)wherein the lumen body is a sufficiently rigid monolithic structurehaving a continuous wall without a stepped portion, said wall formingsaid leading portion, and wherein said leading portion comprises aleading edge; and g) wherein said lumen wall has a cross-sectionalprofile having a uniform width along the insertable portion of the lumenbody; h) wherein said lumen cavity has a first end and a second end,wherein said lumen cavity is sealed at each end thereof; and whereinsaid device includes a mechanism for admitting a liquid into said sealedlumen cavity.
 32. The subperiosteal syringe-elevator assembly of claim31, wherein said plunger seals at least one end of said lumen cavity andwherein an end cap seals at least the other end of said lumen cavity.33. The subperiosteal syringe-elevator assembly of claim 32, whereinsaid mechanism for admitting a liquid into said lumen cavity is providedin said end cap.
 34. A subperiosteal syringe-elevator assembly forseparating the periosteum and admitting particulate bone graft materialwithin a subperiosteal tunnel, comprising: a) a lumen body having aninsertable portion; b) the lumen body having a first opening that isconfigured for insertion into the subperiosteal tunnel and a secondopening configured to remain outside the subperiosteal tunnel duringuse; c) the lumen body having a cavity therein with an uninterruptedsurface and a continuous diameter; d) a plunger sealingly engaging thelumen cavity and being sized to fit within the lumen cavity, and that isintroduced through the second opening; e) the lumen terminating at thefirst opening and having a leading elevator portion that at the firstopening extends longitudinally beyond another lumen portion and is usedto gain access to the subperiosteal tunnel; f) wherein the lumen body isa sufficiently rigid monolithic structure having a continuous wallwithout a stepped portion, said wall forming said leading portion, andwherein said leading portion comprises a leading edge; g) wherein saidlumen wall has a cross-sectional profile having a uniform width alongthe insertable portion of the lumen body; and h) wherein said lumencomprises a longitudinal length with at least one first portion of saidlongitudinal length spanning in a longitudinal direction, and at leastone second portion of said longitudinal length spanning in alongitudinal direction parallel to the first portion, wherein said firstportion comprises a flat portion, and wherein said second portioncomprises a curved portion.
 35. The subperiosteal syringe-elevatorassembly of claim 34, wherein said first portion of said longitudinallength and said second portion of said longitudinal length are disposedon opposite sides of the lumen.
 36. The subperiosteal syringe-elevatorassembly of claim 35, wherein said second portion of said longitudinallength extends longitudinally beyond said first portion of saidlongitudinal length to form the first lumen opening, wherein said secondportion of said longitudinal length forms the leading portion andextends longitudinally beyond said first portion of said longitudinallength.
 37. The subperiosteal syringe-elevator assembly of claim 36,wherein the first lumen opening comprises a beveled opening.
 38. Thesubperiosteal syringe-elevator assembly of claim 36, further comprisingparticulate bone graft material sealingly contained within said lumen.39. The subperiosteal syringe-elevator assembly of claim 38, furthercomprising a growth factor within said lumen.
 40. The subperiostealsyringe-elevator assembly of claim 39, wherein said lumen is constructedfrom a material that allows visibility into said lumen cavity.
 41. Thesubperiosteal syringe-elevator assembly of claim 36, further comprisinga substitute bone material comprising a paste sealingly contained withinsaid lumen.
 42. The subperiosteal syringe-elevator assembly of claim 41,further comprising one or more of a growth factor, collagen, or bindingor adhesive agents contained within said lumen along with the bonematerial.
 43. A subperiosteal syringe-elevator assembly for separatingthe periosteum and admitting particulate bone graft material within asubperiosteal tunnel, comprising: a) a lumen body having an insertableportion; b) the lumen body having a first opening that is configured forinsertion into the subperiosteal tunnel and a second opening configuredto remain outside the subperiosteal tunnel during use; c) the lumen bodyhaving a cavity therein with an uninterrupted surface and a continuousdiameter; d) a plunger sealingly engaging the lumen cavity and beingsized to fit within the lumen cavity, and that is introduced through thesecond opening; e) the lumen terminating at the first opening and havinga leading elevator portion that at the first opening extendslongitudinally beyond another lumen portion and is used to gain accessto the subperiosteal tunnel; f) wherein the lumen body is a sufficientlyrigid monolithic structure having a continuous wall without a steppedportion, said wall forming said leading portion, and wherein saidleading portion comprises a leading edge; and g) wherein said lumen wallhas a cross-sectional profile having a uniform width along theinsertable portion of the lumen body; h) wherein said leading portion ofsaid lumen which at the first opening extends longitudinally beyondanother lumen portion, is coextensive with the lumen cross-sectionalprofile, so as to continue to represent the cross-sectional profile overits leading portion.